MSP-115 Medical Product Safety Regulations

This course provides an overview of national and global regulations governing the safety of medical products including drugs, diagnostics, medical devices, and biologics. Topics include a review of the regulatory agencies; regulations for pre-clinical, clinical, and post-market production safety; and regulations governing the process for monitoring product safety. Upon completion, students should be able to demonstrate a basic understanding of regulatory processes associated with clinical research and describe effective means of compliance.

* The following courses must be completed prior to taking this course., Must complete MSP-110 with minimum grade C